ViroPharma files for stay of action with FDA for Vancocin capsules

By Lisa Kerner

Charlotte, N.C., June 30 - ViroPharma Inc. said it submitted a supplement to its Petition for Stay of Action with the Food and Drug Administration related to the bioequivalence requirements for abbreviated new drug applications that seek to copy Vancocin capsules.

The company claims the FDA's decision to modify the bioequivalence standards for generic copies of Vancocin capsules is scientifically flawed, according to a company news release.

ViroPharma maintains that anything less than an in vivo demonstration of bioequivalence in clostridium difficile-associated disease and enterocolitis caused by Staphylococcus aureus could put patients at risk.

Located in Exton, Pa., ViroPharma develops and commercializes products to treat viral diseases including cytomegalovirus and hepatitis C.

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